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CSL Ltd is seeking a Regulatory CMC Expert for their Tokyo, Japan office. The role focuses on evaluating CMC regulatory aspects, developing strategies, and managing submissions to Japanese Health Authorities for both development and established products.
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Job Summary
The Regulatory CMC Expert evaluates all CMC regulatory aspects related to the assigned products in Japan, developing and executing CMC strategies for development and established products.
This role involves preparing CMC regulatory dossiers, materials for negotiations with Japanese Health Authorities, and interpreting regulatory requirements.
The position requires at least 5 years of pharmaceutical industry experience in CMC and at least 3 years of Regulatory CMC experience for development and/or established products.
Matching Summary
Match Score: 75
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CSL Ltd is seeking a Regulatory CMC Expert for their Tokyo, Japan office. The role focuses on evaluating CMC regulatory aspects, developing strategies, and managing submissions to Japanese Health Authorities for both development and established products.
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Skills & Requirements
Must-have
CMC regulatory aspects
Japanese CTD preparation
Japanese Health Authority interaction
Fluent Japanese and English communication
Nice-to-have
CSL values empathy and collaboration
Leadership capabilities
Organizational values and operational excellence
Key Requirements
At least 5 years pharmaceutical industry experience in CMC